LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 CLAIRE 1/BEIGE- titanium dioxide and zinc oxide powder
LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 CLAIRE 2/BEIGE- titanium dioxide and zinc oxide powder
LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 CLAIRE 3/BEIGE- titanium dioxide and zinc oxide powder
LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 CLAIRE 4/BEIGE- titanium dioxide and zinc oxide powder
LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 MEDIUM 5/BEIGE- titanium dioxide and zinc oxide powder
LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 MEDIUM 6/BEIGE- titanium dioxide and zinc oxide powder
LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 MEDIUM 7/BEIGE- titanium dioxide and zinc oxide powder
LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 OBSCURE 8/BEIGE- titanium dioxide and zinc oxide powder
LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 OBSCURE 9/BEIGE- titanium dioxide and zinc oxide powder
Ventura International LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

L'BEL EFFET PARFAIT LONG LASTING COMPACT POWDER SPF 15

Drug Facts

Active Ingredients	Purpose
TITANIUM DIOXIDE 5.75 %	Sunscreen
ZINC OXIDE 4.90 %	Sunscreen

Uses

Helps prevent sunburn.

Warnings

Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Children under 6 months of age: Ask a doctor.

Other information

Protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENTS

MICA, DIMETHICONE, POLYMETHYLSILSESQUIOXANE, ZINC STEARATE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, TRIMETHYLSILOXYSILICATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, PERFLUOROOCTYL TRIETHOXYSILANE, TOCOPHERYL ACETATE, HYDROGEN DIMETHICONE, PHENOXYETHANOL, CETYL PEG/PPG-10/1 DIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, ALUMINA, HEXYL LAURATE, FRAGRANCE, CAPRYLYL GLYCOL, CRITHMUM MARITIMUM EXTRACT, TRIETHOXYCAPRYLYLSILANE, CHLORPHENESIN, CERAMIDE 3, BUTYLPHENYL METHYLPROPIONAL, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE, HYDROXYCITRONELLAL, CITRONELLOL, GERANIOL, d-LIMONENE, ALPHA-ISOMETHYL IONONE. MAY CONTAIN: IRON OXIDES, TITANIUM DIOXIDE.

Dist. by
Ventura Int Ltd. DBA Belcorp USA, Miami, FL 33126.

PRINCIPAL DISPLAY PANEL - 10 g Container Box - Claire 1/Beige

L'BEL
EFFET PARFAIT
Long lasting compact powder SPF 15

Net wt. 0.35 oz. e (10 g)

PRINCIPAL DISPLAY PANEL - 10 g Container Box - Claire 1/Beige

PRINCIPAL DISPLAY PANEL - 10 g Container Box - Claire 2/Beige

L'BEL
EFFET PARFAIT
Long lasting compact powder SPF 15

Net wt. 0.35 oz. e (10 g)

PRINCIPAL DISPLAY PANEL - 10 g Container Box - Claire 2/Beige

PRINCIPAL DISPLAY PANEL - 10 g Container Box - Claire 3/Beige

L'BEL
EFFET PARFAIT
Long lasting compact powder SPF 15

Net wt. 0.35 oz. e (10 g)

PRINCIPAL DISPLAY PANEL - 10 g Container Box - Claire 3/Beige

PRINCIPAL DISPLAY PANEL - 10 g Container Box - Claire 4/Beige

L'BEL
EFFET PARFAIT
Long lasting compact powder SPF 15

Net wt. 0.35 oz. e (10 g)

PRINCIPAL DISPLAY PANEL - 10 g Container Box - Claire 4/Beige

PRINCIPAL DISPLAY PANEL - 10 g Container Box - Medium 5/Beige

L'BEL
EFFET PARFAIT
Long lasting compact powder SPF 15

Net wt. 0.35 oz. e (10 g)

PRINCIPAL DISPLAY PANEL - 10 g Container Box - Medium 5/Beige

PRINCIPAL DISPLAY PANEL - 10 g Container Box - Medium 6/Beige

L'BEL
EFFET PARFAIT
Long lasting compact powder SPF 15

Net wt. 0.35 oz. e (10 g)

PRINCIPAL DISPLAY PANEL - 10 g Container Box - Medium 6/Beige

PRINCIPAL DISPLAY PANEL - 10 g Container Box - Medium 7/Beige

L'BEL
EFFET PARFAIT
Long lasting compact powder SPF 15

Net wt. 0.35 oz. e (10 g)

PRINCIPAL DISPLAY PANEL - 10 g Container Box - Medium 7/Beige

PRINCIPAL DISPLAY PANEL - 10 g Container Box - Obscure 8/Beige

L'BEL
EFFET PARFAIT
Long lasting compact powder SPF 15

Net wt. 0.35 oz. e (10 g)

PRINCIPAL DISPLAY PANEL - 10 g Container Box - Obscure 8/Beige

PRINCIPAL DISPLAY PANEL - 10 g Container Box - Obscure 9/Beige

L'BEL
EFFET PARFAIT
Long lasting compact powder SPF 15

Net wt. 0.35 oz. e (10 g)

PRINCIPAL DISPLAY PANEL - 10 g Container Box - Obscure 9/Beige

LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 CLAIRE 1/BEIGE
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-132
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0575 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ZINC STEARATE (UNII: H92E6QA4FV)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ALUMINUM OXIDE (UNII: LMI26O6933)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-132-02	1 in 1 BOX	08/18/2018
1	NDC:14783-132-01	12 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC:14783-132-04	1 in 1 BOX	08/18/2018
2	NDC:14783-132-03	10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/18/2018

LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 CLAIRE 2/BEIGE
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-133
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0575 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ZINC STEARATE (UNII: H92E6QA4FV)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ALUMINUM OXIDE (UNII: LMI26O6933)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-133-02	1 in 1 BOX	08/18/2018
1	NDC:14783-133-01	12 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC:14783-133-04	1 in 1 BOX	08/18/2018
2	NDC:14783-133-03	10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/18/2018

LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 CLAIRE 3/BEIGE
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-134
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0575 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ZINC STEARATE (UNII: H92E6QA4FV)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ALUMINUM OXIDE (UNII: LMI26O6933)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-134-02	1 in 1 BOX	08/18/2018
1	NDC:14783-134-01	12 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC:14783-134-04	1 in 1 BOX	08/18/2018
2	NDC:14783-134-03	10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/18/2018

LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 CLAIRE 4/BEIGE
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-135
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0575 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ZINC STEARATE (UNII: H92E6QA4FV)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ALUMINUM OXIDE (UNII: LMI26O6933)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-135-02	1 in 1 BOX	08/18/2018
1	NDC:14783-135-01	12 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC:14783-135-04	1 in 1 BOX	08/18/2018
2	NDC:14783-135-03	10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/18/2018

LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 MEDIUM 5/BEIGE
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-136
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0575 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ZINC STEARATE (UNII: H92E6QA4FV)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ALUMINUM OXIDE (UNII: LMI26O6933)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-136-02	1 in 1 BOX	08/18/2018
1	NDC:14783-136-01	12 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC:14783-136-04	1 in 1 BOX	08/18/2018
2	NDC:14783-136-03	10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/18/2018

LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 MEDIUM 6/BEIGE
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-137
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0575 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ZINC STEARATE (UNII: H92E6QA4FV)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ALUMINUM OXIDE (UNII: LMI26O6933)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-137-02	1 in 1 BOX	08/18/2018
1	NDC:14783-137-01	12 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC:14783-137-04	1 in 1 BOX	08/18/2018
2	NDC:14783-137-03	10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/18/2018

LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 MEDIUM 7/BEIGE
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-138
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0575 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ZINC STEARATE (UNII: H92E6QA4FV)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ALUMINUM OXIDE (UNII: LMI26O6933)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-138-02	1 in 1 BOX	08/18/2018
1	NDC:14783-138-01	12 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC:14783-138-04	1 in 1 BOX	08/18/2018
2	NDC:14783-138-03	10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/18/2018

LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 OBSCURE 8/BEIGE
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-139
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0575 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ZINC STEARATE (UNII: H92E6QA4FV)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ALUMINUM OXIDE (UNII: LMI26O6933)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-139-02	1 in 1 BOX	08/18/2018
1	NDC:14783-139-01	12 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC:14783-139-04	1 in 1 BOX	08/18/2018
2	NDC:14783-139-03	10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/18/2018

LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 OBSCURE 9/BEIGE
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-151
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0575 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ZINC STEARATE (UNII: H92E6QA4FV)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ALUMINUM OXIDE (UNII: LMI26O6933)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-151-02	1 in 1 BOX	08/18/2018
1	NDC:14783-151-01	12 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC:14783-151-04	1 in 1 BOX	08/18/2018
2	NDC:14783-151-03	10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/18/2018

Labeler - Ventura International LTD (603192787)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(14783-132, 14783-133, 14783-134, 14783-135, 14783-136, 14783-137, 14783-138, 14783-139, 14783-151)

Revised: 9/2018

Document Id: 7f94ecd8-9e7d-4ffd-9f24-46316997f3dc

Set id: 67263ec5-33b2-4184-a938-d04288fd69fe

Version: 1

Effective Time: 20180928

Ventura International LTD